Label: VAPOR INHALER LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH- levmetamfetamine inhalant

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2024

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  • Active ingredient

    per inhaler:

    Levmetamfetamine 50mg

  • Purpose

    Nasal Decongestant

  • Use:

    For temporary relief of nasal congestion due to

    • the common cold
    • hay fever or upper respiratory allergies
  • Warnings

    When using this product

    • do not exceed recommended dosage
    • temporary burning, stinging, sneezing, or increased nasal discharge may occur
    • use of this container by more than one person may spread infection

    • do not use for more than 7 days
    • use only as directed
    • frequent or prolonged use may cause nasal congestion to recur or worsen

    Stop use and ask a doctor if symptoms persist

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine
    • do not use more often than every 2 hours
    adults and children 12 years of age and over 2 inhalations in each nostril
    children 6 to under 12 years of age (with adult supervision) 1 inhalation in each nostril
    children under 6 years of age ask a doctor
    children under 2 years of age do not use
  • Other information

    this inhaler is effective for a minimum of 3 months after first use • keep inhaler tightly closed • store at 59°-86° F (15°-30° C)

  • Inactive ingredients

    bornyl acetate, camphor, lavender oil, menthol, methyl salicylate

  • Principal Display Panel - 198 mg Blister Pack Label

    NDC 36800-294-07

    +TopCare® health™

    Vapor
    Inhaler

    OUR PHARMACISTS
    RECOMMENDED

    LEVMETAMFETAMINE - NASAL DECONGESTANT

    Temporary Relief of Nasal
    Congestion Due to:

    • Colds • Hay Fever

    • Upper Respiratory Allergies

    NET WT 0.007 OZ (198mg)

    Principal Display Panel - 198 mg Blister Pack Label
  • Principal Display Panel - 198 mg Inhaler Label

    NDC 36800-294-07

    +TopCare®
    health™

    Vapor
    Inhaler

    LEVMETAMFETAMINE - NASAL DECONGESTANT

    NET WT 0.007 OZ (198mg)

    Principal Display Panel - 198 mg Inhaler Label
  • INGREDIENTS AND APPEARANCE
    VAPOR INHALER   LEVMETAMFETAMINE NASAL DECONGESTANT, TOPCARE HEALTH
    levmetamfetamine inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-294
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Levmetamfetamine (UNII: Y24T9BT2Q2) (Levmetamfetamine - UNII:Y24T9BT2Q2) Levmetamfetamine50 mg
    Inactive Ingredients
    Ingredient NameStrength
    Bornyl acetate (UNII: 213431586X)  
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    Lavender oil (UNII: ZBP1YXW0H8)  
    Menthol (UNII: L7T10EIP3A)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-294-071 in 1 BLISTER PACK02/19/2021
    1198 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/19/2021
    Labeler - Topco Associates LLC (006935977)
    Registrant - Aphena Pharma Solutions MD, LLC (829739833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(36800-294)
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